obeticholic acid
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FDA turns down Intercept’s long-anticipated NASH drug
The FDA has requested additional data from the company’s clinical trial. Intercept’s CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
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Intercept hits regulatory snag at FDA, likely delaying NASH drug’s approval
The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Genfit CEO says company emphasizes patient access as it considers price for its NASH drug
In an interview at the BIO CEO & Investor Conference in New York Monday, CEO Pascal Prigent said barriers to access rather than reimbursement represent the biggest concern for NASH drugs like elafibranor. As a ballpark estimate, a list price in the $10,000 range is possible.
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Intercept hits slight delay in NASH drug approval, but analysts remain upbeat
While the FDA’s scheduling an expert panel meeting for obeticholic acid after the original action date would delay its decision, an analyst wrote it would still likely be the first to win approval in NASH.
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Intercept’s Ocaliva shows continued improvement in NASH fibrosis at European liver conference
The company’s stock was nevertheless down more than 13 percent amid investor concerns about lack of intent-to-treat analysis on two-stage fibrosis improvement and gall stone events.
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Intercept could score first NASH drug approval on positive Phase III data
Shares of the New York-based company jumped nearly 20 percent Tuesday on news that the REGENERATE study of obeticholic acid showed strong improvement in NASH-related liver fibrosis.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
